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NCT02691741

Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

Completed NA Results posted Last updated 27 September 2019
What this trial tests

NA trial testing AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in Cataracts in 215 participants. Completed in 17 July 2017.

Timeline
29 April 2016
Primary endpoint
17 July 2017
17 July 2017

Quick facts

Lead sponsorAlcon Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment215
Start date29 April 2016
Primary completion17 July 2017
Estimated completion17 July 2017

Drugs / interventions tested

Conditions studied

Sponsor

Alcon Research — full company profile →

Who can join

22 and older, any sex, with Cataracts. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 Primary · Day 120-180 from second eye implantation

VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

GroupValue95% CI
TFNT000.053± 0.0134
839MP0.115± 0.0139
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 Secondary · Day 120-180 from second eye implantation

VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

GroupValue95% CI
TFNT000.053± 0.0134
839MP0.115± 0.0139
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 Secondary · Day 120-180 from second eye implantation

VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

GroupValue95% CI
TFNT000.015± 0.0109
839MP0.004± 0.0113
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 Secondary · Day 120-180 from second eye implantation

VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

GroupValue95% CI
TFNT000.083± 0.0116
839MP0.133± 0.0121
Mean Photopic Binocular Defocus Curve at Day 120-180 Secondary · Day 120-180 from second eye implantation

A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.

0.0 Diopter (D)
GroupValue95% CI
TFNT00-0.048± 0.0811
839MP-0.069± 0.0831
-0.5D
GroupValue95% CI
TFNT000.016± 0.0835
839MP-0.018± 0.0951
-1.0D
GroupValue95% CI
TFNT000.093± 0.0993
839MP0.048± 0.1207
-1.5D
GroupValue95% CI
TFNT000.038± 0.0983
839MP0.084± 0.1111
-2.0D
GroupValue95% CI
TFNT000.011± 0.0859
839MP0.117± 0.1039
-2.5D
GroupValue95% CI
TFNT000.027± 0.1013
839MP0.063± 0.1399
-3.0D
GroupValue95% CI
TFNT000.118± 0.1297
839MP0.077± 0.1241
-3.5D
GroupValue95% CI
TFNT000.231± 0.1252
839MP0.206± 0.1415
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 Secondary · Day 120-180 from second eye implantation

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

3 CPD
GroupValue95% CI
TFNT001.720± 0.2025
839MP1.735± 0.1894
6 CPD
GroupValue95% CI
TFNT001.860± 0.2635
839MP1.831± 0.2699
12 CPD
GroupValue95% CI
TFNT001.482± 0.3853
839MP1.496± 0.4328
18 CPD
GroupValue95% CI
TFNT001.021± 0.3778
839MP1.022± 0.4197
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 Secondary · Day 120-180 from second eye implantation

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

3 CPD
GroupValue95% CI
TFNT001.721± 0.2041
839MP1.754± 0.2225
6 CPD
GroupValue95% CI
TFNT001.790± 0.3282
839MP1.797± 0.3538
12 CPD
GroupValue95% CI
TFNT001.434± 0.4616
839MP1.426± 0.4570
18 CPD
GroupValue95% CI
TFNT001.007± 0.3769
839MP1.033± 0.4316
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 Secondary · Day 120-180 from second eye implantation

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

1.5 CPD
GroupValue95% CI
TFNT001.611± 0.2293
839MP1.600± 0.2226
3 CPD
GroupValue95% CI
TFNT001.648± 0.3115
839MP1.682± 0.2639
6 CPD
GroupValue95% CI
TFNT001.667± 0.4284
839MP1.676± 0.4243
12 CPD
GroupValue95% CI
TFNT001.208± 0.5262
839MP1.227± 0.5307
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 Secondary · Day 120-180 from second eye implantation

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

1.5 CPD
GroupValue95% CI
TFNT001.579± 0.2581
839MP1.538± 0.2568
3 CPD
GroupValue95% CI
TFNT001.642± 0.2696
839MP1.682± 0.2642
6 CPD
GroupValue95% CI
TFNT001.550± 0.4791
839MP1.607± 0.4898
12 CPD
GroupValue95% CI
TFNT001.146± 0.5623
839MP1.175± 0.6062
Subject Satisfaction Recorded at Day 120-180 Secondary · Day 120-180 from second eye implantation

At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.

Yes
GroupValue95% CI
TFNT0095.7
839MP96.6
No
GroupValue95% CI
TFNT003.2
839MP2.3
Missing
GroupValue95% CI
TFNT001.1
839MP1.1

Adverse events — posted to ClinicalTrials.gov

Time frame: IOL implantation through study completion, an average of 7 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TFNT00 - 1st Eye
Serious: 0/93 (0%)
Deaths: 0/93
TFNT00 - 2nd Eye
Serious: 0/93 (0%)
Deaths: 0/93
TFNT00 - Systemic
Serious: 2/93 (2%)
Deaths: 0/93
839MP - 1st Eye
Serious: 3/89 (3%)
Deaths: 0/89
839MP - 2nd Eye
Serious: 2/87 (2%)
Deaths: 0/87
839MP - Non-Study Eye
Serious: 0/2 (0%)
Deaths: 0/2
839MP - Systemic
Serious: 0/89 (0%)
Deaths: 0/89

Serious adverse events (6 terms)

ReactionSystemTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - Systemic839MP - 1st Eye839MP - 2nd Eye839MP - Non-Study Eye839MP - Systemic
Cystoid macular oedemaEye disorders———————
NauseaGastrointestinal disorders———————
Device dislocationProduct Issues———————
Pleural effusionRespiratory, thoracic and mediastinal disorders———————
Intra-ocular injectionSurgical and medical procedures———————
Intraocular lens implantSurgical and medical procedures———————
Other adverse events (2 terms — click to expand)

ReactionSystemTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - Systemic839MP - 1st Eye839MP - 2nd Eye839MP - Non-Study Eye839MP - Systemic
Halo visionEye disorders———————
Posterior capsule opacificationEye disorders———————

Most-reported serious reactions: Cystoid macular oedema, Nausea, Device dislocation, Pleural effusion, Intra-ocular injection, Intraocular lens implant.

Data from ClinicalTrials.gov NCT02691741 adverse events section.

Sponsor's own description

The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing